Celltrion Secures the EC’s Approval for Avtozma (Biosimilar, RoActemra)
Shots:
- Following the US FDA approval, the EC has approved Avtozma (biosimilar, RoActemra) to treat mod. to sev. rheumatoid arthritis (RA), active systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA), and giant cell arteritis (GCA)
- Approval was based on the P-III trial of Avtozma (tocilizumab-anoh) vs RoActemra (tocilizumab) in mod. to sev. RA pts demonstrated biosimilarity, and change in disease activity score using 28 joints (DAS28)-ESR (1EP) at wk.12 & the final results supported comparability in secondary efficacy, PK, safety, and immunogenicity up to wk. 52
- Avtozma is a recombinant humanized mAb that targets the IL-6 receptor
Ref: Celltrion | Image: Celltrion
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